알테오젠 US CMO PIP (Person-in-Plant)
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Alteogen Inc. is seeking a highly experienced and technically proficient individual for a critical
Person-In-Plant (PIP) role to manage and supervise the Biologics Drug Substance (DS)
Technology Transfer (TT) and subsequent Process Performance Qualification (PPQ) campaign.
This is a high-impact contract position responsible for ensuring the successful, compliant, and timely
execution of a strategic manufacturing transfer.
1. Position Overview
Position Title: Biologics DS Tech Transfer & PPQ PIP (Manager/Assoc. Director Level)
Employment Type: Contract Base
Contract Term Tentative: December 2025 – June 2027 (Schedule is flexible upon project timeline)
Salary: To be discussed
Location: Boston, MA Area, USA (CMO Site)
Travel: Required domestic travel to the CMO site and probably international travel to Daejeon, South Korea Headquarters for senior management reporting.
Core Project: ALT-## Drug Substance (CHO cell base) Commercial Production TT & PPQ
2. Role Summary: On-Site Technical & Quality Oversight
This position serves as the on-site technical and quality representative for Alteogen, Inc., responsible for providing direct, real-time oversight of all technical transfer and PPQ activities at the US CMO site. The PIP will directly monitor GMP operations, participate in key quality discussions, and ensure all manufacturing and documentation processes align with Alteogen’s Quality Management System (QMS/PQS) and global regulatory expectations.
3. Key Responsibilities
A. Tech Transfer Execution and Operational Oversight
1. Manage and supervise all aspects of the Biologics DS process transfer (USP/DSP) from the sending site to the receiving CMO, ensuring process alignment and facility fit.
2. Provide Person-In-Plant (PIP) coverage throughout all technical runs and critical PPQ batches, verifying compliance during production site walkthroughs and GMP operations.
3. Support the Change Management process, evaluating changes to minimize inherent quality risks and mitigate potential regulatory inspection deficiencies or warning letters.
4. Monitor product/sample shipment processes, including those under shipping validation, and track the overall Drug Product/Substance lifecycle.
B. Quality Management and Compliance Decision-Making
1. Act as the authorized local representative to make quality decisions on behalf of Alteogen Inc. regarding GMP compliance issues, in strict accordance with the company's QMS.
2. Perform rapid primary review and local approval where feasible of all GMP data generated from USP (Upstream) and DSP (Downstream) production.
3. Conduct comprehensive review of CMO Batch Records and QC testing results, including raw data review when necessary, to guarantee the quality of ALT-## batches. ALTEOGEN Inc. For recruitment only Confidential
4. Review and assess Validation Protocols/Reports against actual operational parameters, as well as all associated Deviation, CAPA, and Complaint records.
5. Maintain oversight of Data Integrity control status and Environmental Monitoring activities.
C. Communication and Reporting
1. Establish and maintain proficient communication with the CMO management using English, while ensuring clear and continuous real-time communication with the Korean Headquarters.
2. Drive timely GMP documentation and recording to support the prompt supply of materials and successful PPQ completion.
3. Generate and share daily and weekly reports to the Head Office representative, summarizing GMP compliance status, production progress, and all critical quality issues.
4. Conduct regular meetings with CMO Quality and Production department managers to monitor production status and secure robust GMP documents that establish a strong quality rationale for regulatory filing.
4. Required Qualifications
• Experience:
o Minimum 10 years of total experience in the biopharmaceutical industry.
o Proven experience at the Manager level or above (e.g., Associate Director, Director).
o 3+ years of demonstrated, dedicated Person-In-Plant (PIP) performance experience.
• Technical Expertise: Extensive experience in Biologics (CHO cell base) covering
Development, GMP Manufacturing, Quality Assurance (QA), and/or Technology Transfer.
• Quality & Compliance:
o Experience in QA work at a global bio-pharmaceutical company, including deep
knowledge of QMS processes (Deviation, Change Control, CAPA, Complaint
management).
o Experience managing or successfully navigating cGMP-related Regulatory Agency
Inspections.
• Eligibility: No disqualifications for working legally in the United States.
• Language: High proficiency in English (verbal and written) for technical and management
communications. (Note: Korean-American background is preferred but not required for this
role.)
5. Contact Information
• Email: career@alteogen.com
